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EC number: 202-992-2
CAS number: 101-96-2
Percent Liver Weight Differences from Control Groups
Dose level (mg/kg/day):
Relative to body weight
*: P<0.05, **: P<0.01
Test Item-Related Microscopic Liver Findings (including premature
The objectives of this study were to
determine thepotential toxic effects of
N,N’-Di-sec-butyl-p-phenylenediamine when given orally by gavage to
Wistar Han rats, and to evaluate the potential to affect male and female
reproductive performance such as gonadal function, mating behaviour,
conception, parturition and early postnatal development. Males
were treated for 29 days and females that delivered were treated for
50-54 days. Females which failed to deliver were
treated for 32-54 days.
In addition, parental, reproduction (up to and including
implantation) and developmental (from implantation onwards) No Observed
Adverse Effect Levels (NOAELs) were evaluated.
The dose levels in this study were selected to be 0, 10, 30, 60
mg/kg/day, based on the results of the dose range finder (Test Facility
Study No. 20140514).
Chemical analyses of formulations were conducted once during the study
to assess accuracy, homogeneity.
The following parameters and end points were evaluated in this
study: mortality/moribundity, clinical signs, body weight and food
consumption, estrous cycle determination,measurement of thyroid hormone
T4 (F0-males), gross necropsy findings, organ weights and
In addition, the following reproduction/developmental parameters
were determined: mating and fertility indices, precoital time, number of
implantation sites, gestation index and duration, parturition, maternal
care, sex ratio and early postnatal pup development (mortality, clinical
signs, body weights, sex, anogenital distance, areola/nipple retention
and macroscopy, measurement of thyroid hormone T4 (PND 14-16 pups)).
Formulation analysis confirmed that formulations of test item in
polyethylene glycol 400 were prepared accurately and homogenously. For
the formulation of Group 4, the mean accuracy was slightly below the
target concentration (i.e. 89% of target). As the deviation from the
target concentration was very small, accuracy of Group 4 formulations
was considered acceptable.
Parental toxicity was observed at 60 mg/kg.
At 60 mg/kg bw/day there was one treatment-related death: One male
had to be sacrificed in extremis on Day 21 of treatment. This animal was
noted with hunched posture, labored respiration, rales, diarrhea, a lean
posture and piloerection, and had a remarkable body weight loss (about
16% over one week). Moderate hepatocellular necrosis of the periportal
area was considered to be the main cause of moribundity for this animal
and as the liver is identified asa[GS1] target
organ for the test item, this death was considered to be related to the
treatment with the test item.
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